A Study to Compare Tenofovir Versus the Combination of Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B in Patients With Normal ALT - Tabular View

Tracking Information
First Received Date ^ICMJE	July 25, 2007
Last Updated Date	February 27, 2009
Start Date ^ICMJE	August 2007
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 27, 2009)	Suppression of HBV DNA < 400 copies/mL [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: November 14, 2007)	Suppression of HBV DNA < 169 copies/mL [ Time Frame: 48 weeks ]
Change History	Complete list of historical versions of study NCT00507507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 27, 2009)	HBeAg seroconversion [ Time Frame: Week 144 ] [ Designated as safety issue: No ] Development of resistance mutations [ Time Frame: Week 144 ] [ Designated as safety issue: No ] HBsAg loss [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: November 14, 2007)	Suppression of HBV DNA < 169 copies/mL [ Time Frame: 96 weeks ]

Descriptive Information
Brief Title ^ICMJE	A Study to Compare Tenofovir Versus the Combination of Tenofovir Plus Emtricitabine for the Treatment of Chronic Hepatitis B in Patients With Normal ALT
Official Title ^ICMJE	A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B
Brief Summary	The main objective of the study is to evaluate the antiviral activity of tenofovir monotherapy versus tenofovir plus emtricitabine combination therapy for the treatment of chronic Hepatitis B
Detailed Description	The efficacy of tenofovir monotherapy versus tenofovir plus emtricitabine combination therapy will be evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes) and the development of any drug resistant mutations. The safety and tolerability of both tenofovir and tenofovir plus emtricitabine will also be evaluated by routine monitoring for adverse events and changes in laboratory parameters.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Chronic Hepatitis B
Intervention ^ICMJE	Drug: tenofovir disoproxil fumarate Drug: tenofovir disoproxil plus emtricitabine
Study Arms / Comparison Groups	Experimental: Tenofovir DF 300 mg + Emtricitabine 200 mg Experimental: Tenofovir DF
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	126
Estimated Completion Date	March 2011
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Chronic HBV infection, defined as positive serum HBsAg for at least 6 months or HBsAg positive > 3 months and positive for IgG anti-HBc 18 through 69 years of age, inclusive HBeAg positive HBV DNA >= 10^8 copies/mL ALT <= ULN Willing and able to provide written informed consent Negative serum beta-HCG (for females of childbearing potential only) Calculated creatinine clearance >= 70 mL/min Hemoglobin >=10 g/dL Neutrophils >= 1,500 /mm3 No prior oral HBV therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for HBV infection). Exclusion Criteria: Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study. Males and females of reproductive potential who are not willing to use an "effective" method of contraception during the study. Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 x ULN, PT >1.2 x ULN, platelets < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage). Received interferon (pegylated or not) therapy within 6 months of the screening visit alpha-fetoprotein > 50 ng/mL Evidence of hepatocellular carcinoma (HCC) Co infection with HCV (by serology), HIV, or HDV. Significant renal, cardiovascular, pulmonary, or neurological disease. Received solid organ or bone marrow transplantation. Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion. Has proximal tubulopathy. Known hypersensitivity to the study drugs, the metabolites or formulation excipients.
Gender	Both
Ages	18 Years to 69 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Canada, France, Germany, Hong Kong, New Zealand, Poland, Singapore, Taiwan, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00507507
Responsible Party	David Oldach, MD/Director Clinical Research, Gilead Sciences
Study ID Numbers ^ICMJE	GS-US-203-0101
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Gilead Sciences
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP